Mendaera, a robotics firm, introduced it has been granted FDA 510(okay) clearance for Focalist, a handheld robotic system, which goals to mix handheld robotics with real-time imaging to allow clinicians to position needles with precision.
Mendaera mentioned the system integrates robotics, ultrasound imaging and superior software program to make medical procedures extra accessible.
Amongst Focalist’s options are touchscreen focusing on, robotic needle positioning and steady needle depth monitoring, enabling a reproducible process expertise.
Whereas needle placement is used for a wide range of procedures and in a broad vary of medical settings, the preliminary focus of the system might be in urology. Full commercialization is predicted in 2026.
“Exact placement of needles to carry out a variety of procedures, organ entry, biopsies, vascular entry or remedy supply, as examples, is a really difficult, however foundational method that underpins most affected person care journeys,” Josh DeFonzo, cofounder and CEO of Mendaera, mentioned in an announcement.
“Our mission is to make sure that these procedures are delivered safely and effectively throughout the healthcare system by enabling extra suppliers with the arrogance wanted to carry out these methods. Robotics have been proven to extend supplier capabilities in advanced procedures and we intend to reveal that the identical might be true in on a regular basis care.”
THE LARGER TREND
In April, Mendaera collaborated with fellow needle firm Prepare dinner Medical to supply Prepare dinner’s needles as an choice mixed with the Mendaera robotic.
The collaboration goals to create “cutting-edge” instruments for needle-based interventions in urological procedures. Prepare dinner’s EchoTip expertise was built-in into Mendaera’s instrumentation choices.
In 2024, EchoNous, an organization specializing in moveable ultrasound expertise, partnered with Mendaera, enabling compatibility between EchoNous’ moveable ultrasound machine Kosmos and Mendaera’s handheld robotic interventional platform.
That very same 12 months, Mendaera introduced the closing of a $73 million Collection B funding spherical. The funds have been used to additional the corporate’s efforts to scale robotics and AI throughout mainstream medical procedures.
Mendaera acquired Avail Medsystems’ telepresence expertise final 12 months. Mendaera utilized its expanded portfolio to extend affected person entry to interventions to assist enhance affected person care inside healthcare programs.
In 2023, Mendaera secured $24 million in Collection A funding in a spherical led by Lux Capital.
The corporate mentioned it will use the funds to open a manufacturing facility to finish growth of its expertise and acquire FDA clearance.
